<div><p><strong>About Cleerly</strong></p> <p>We’re Cleerly – a healthcare company that’s revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world’s leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. </p> <p>Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly’s solutions are supported by more than a decade of performing some of the world’s largest clinical trials to identify important findings beyond symptoms that increase a person’s risk of heart attacks. </p> <p>At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. </p> <div> <div> <div> <div> <div> <div> <div> <div> <div> <div> <div> <div>While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time.</div> </div> </div> </div> </div> </div> </div> </div> <div> </div> </div> </div> </div> </div></div><p><strong>About the Opportunity</strong></p> <p>As Senior Manager, Regulatory Affairs, you will oversee regulatory activities and personnel to support Cleerly’s product development, global market access and compliance objectives. You will help contribute to Cleerly’s regulatory team in the areas of regulatory strategy, regulatory intelligence, and regulatory operations including submissions.</p> <p> </p> <p>You will build a team of regulatory professionals, ensuring high-quality execution of Cleerly’s regulatory strategy, submissions; provide guidance to cross-functional teams, and adherence to evolving global regulatory requirements. This role combines hands-on regulatory expertise with leadership responsibilities, contributing to departmental strategy and talent development.  </p> <p> </p> <p>You will support inspections and/or audits from health authorities, support and/or lead global regulatory and compliance initiatives and provide regulatory and compliance guidance while helping to develop, lead and manage the regulatory team.</p> <p> </p> <p><strong>Responsibilities</strong></p> <p><em>Digital Health &amp; SaMD Regulatory Leadership</em></p> <ul> <li>Lead the regulatory strategy for Cleerlys AI and Software as a Medical Device (SaMD). This includes authoring and managing submissions for key markets (e.g., FDA 510(k), De Novo; EU CE Marking under MDR).</li> <li>You will serve as the subject matter expert on SaMD regulations, ensuring our AI/ML-powered products meet and exceed global standards for safety, efficacy, and cybersecurity.</li> </ul> <p><em>Advanced Imaging &amp; Technology Compliance</em></p> <ul> <li>Collaborate closely with R&amp;D and product teams to ensure regulatory requirements are integrated into the design and development of our Cleerly’s software and AI medical devices.</li> <li> Provide guidance on verification and validation activities, clinical data requirements, and usability engineering to support our product claims and intended use.</li> </ul> <p><em>Proactive Regulatory Intelligence</em></p> <ul> <li>Develop and maintain a robust regulatory intelligence program to monitor, analyze, and communicate changes in the global regulatory environment.</li> <li>You will translate new regulations, guidance documents, and standards into actionable strategies, ensuring Cleerly stays ahead of the curve in areas like AI/ML transparency, data privacy, and interoperability.</li> </ul> <p><em>Advertising &amp; Promotional Governance</em></p> <ul> <li>Establish and manage the Ad Promo review process to ensure all commercial and marketing materials are compliant, truthful, and non-misleading.</li> <li>You will work cross-functionally with commercial teams to substantiate claims and align promotional activities with cleared/approved product labeling, mitigating compliance risk.</li> </ul> <p><em>Scalable Process Management</em></p> <ul> <li>Drive the optimization of regulatory workflows and information systems. This includes refining submission templates, managing regulatory documentation within the Quality Management System (QMS), and implementing efficient process management tools.</li> <li>Your goal is to build a scalable and agile regulatory operations framework that supports rapid innovation.</li> </ul> <p><em>End-to-End Regulatory Compliance:</em></p> <ul> <li>Champion a culture of regulatory compliance throughout the organization.</li> <li>Your expertise will be crucial during internal and external audits (e.g., FDA inspections, Notified Body audits), ensuring our operations are consistently inspection-ready.</li> </ul> <p><em> </em></p> <p><em>People Leadership &amp; Team Management:</em></p> <ul> <li> Manage and mentor regulatory staff, providing coaching, feedback, and professional development.</li> <li>Delegate responsibilities effectively, balancing oversight with empowerment of team members.</li> <li>Conduct performance reviews and contribute to talent management practices.</li> </ul> <p> </p> <p>Other Responsibilities</p> <ul> <li>Maintain knowledge of industry trends, regulatory changes, and emerging best practices by reviewing relevant resources regularly.</li> <li>Contribute to the development and maintenance of Regulatory Affairs working practices and Standard Operating Procedures.</li> <li>Performs other duties as required or assigned to enable effective functioning of the Regulatory Affairs department.</li> </ul> <p> </p> <p><strong>Requirements </strong></p> <ul> <li>Minimum 10 years of medical device experience in a regulatory affairs role required.</li> <li>Minimum 5 years’ experience directly related to AI/ML-based medical devices or software as a medical device (SAMD).</li> <li> Minimum 5 years’ direct people management experience preferred (e.g., leading individual contributors or project teams) preferred.</li> <li>Experience in global regulatory submittals and applications for medical devices required (AI/ML SaMD preferred).</li> <li>Experience in supporting External 3rd Party Audits and Inspections required.</li> <li>Education: B.S. or higher degree in a Life Science, Engineering or related discipline.</li> <li>Regulatory Affairs Certification (RAC) preferred.</li> <li>Demonstrated experience in developing regulatory strategy for novel software (SaMD) or AI/ML-driven medical devices is required.</li> <li>Experience with the De Novo classification process and/or Breakthrough Device Designation program is highly desirable.</li> <li>Proven ability to collaborate with and influence cross-functional technical teams (e.g., data science, engineering) to achieve regulatory objectives</li> <li>Demonstrated knowledge and experience in the identification and interpretation of global regulations, guidelines, and compliance. Must be able to independently coordinate and oversee interdisciplinary project team in quality and timely delivery and compilation and retention of submission documents.</li> <li>Excellent organizational, writing and verbal communication skills.</li> </ul> <p><strong>Salary*</strong>: $230,000 - $253,000</p> <p> <em>*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). We hire employees anywhere within the United States and account for geography when determining base salary.</em></p><div><p><strong>Working at Cleerly takes HEART. Discover our Core Values:</strong></p> <ul> <li><strong>H: Humility</strong>- be a servant leader</li> <li><strong>E: Excellence</strong>- deliver world-changing results</li> <li><strong>A: Accountability</strong>- do what you say; expect the same from others</li> <li><strong>R: Remarkable</strong>- inspire &amp; innovate with impact</li> <li><strong>T: Teamwork</strong>- together we win</li> </ul> <p><span>Don’t meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences. <em>Job duties, activities and responsibilities are subject to change by our company.</em></span></p> <p><strong><em>OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER.</em></strong><em><span>  We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.</span></em></p> <p>By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (<a href="https://cleerlyhealth.com/privacy-policy)">https://cleerlyhealth.com/privacy-policy)</a>. All official emails will come from @cleerlyhealth.com email accounts. </p> <p><span>#Cleerly</span></p></div>

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